There are numerous medical conditions which are hard to diagnose. Often diagnosis by a physician is based on the physician's observation of combinations of symptoms in a patient. This sometimes leads to misdiagnosis. Furthermore, the patient's response to a treatment, whether drug or other modality is often followed up by physician's observation.
Many laboratory tests are performed in the diagnostic arena on a bodily specimen or fluid to determine a biological condition in a patient. However, these tests are performed off-line in diagnostic laboratories. Often, the laboratory services are only provided during a single 8-hour shift during the day and tend to be labor intensive.
Some prior art publications in the field include, inter alia,
U.S. Pat. No. 8,116,984 to Davis et al., discloses a method of quantifying CD64 and CD163 expression in leukocytes and, specifically to a kit for use with a flow cytometer including a suspension of quantitative fluorescent microbead standards, fluorescent labeled antibodies directed to CD64 and CD163, and analytical software. The software is used to take information on the microbead suspension and fluorescent labeled antibodies from a flow cytometer and analyze data, smooth curves, calculate new parameters, provide quality control measures and notify of expiration of the assay system.
Several developments have been published in the micro-fluidics field, such as: US2006215155A, which describes a flow cell comprising a layered arrangement of three plates (3-5) in which an intermediate plate (4) consisting of a flexible material is inserted between plates (3, 5) consisting of a more solid material, and at least one of the plates comprises at least one recess (15, 17) for receiving fluid, that is bordered by another plate (3, 5) of the layered arrangement. Such recesses are especially microchannels and reaction chambers. According to the invention, the plates are interconnected by means arranged parallel to the plate plane at a distance to the recess, compressing the intermediate plate.
WO12019599A describes a microfluidic device for transporting a fluid, in particular a micropump or microvalve. The device according to the invention is characterized by films (2, 3), which lie against each other at film surfaces facing each other and are connected to each other in such a way that a transport channel (19) to be formed between the films (2, 3) is defined, and by deflecting apparatuses for forming the transport channel (19) by jointly deflecting the films (2, 3) lying against each other in a direction perpendicular to the film surfaces, wherein a deflecting surface region (12) of the rear film (2) in the deflection direction lies within the deflecting surface region (14) of the front film (3) in the deflection direction defined by the connection (15) between the films (2, 3).
US2012187117A discloses a fluid reservoir, in particular a fluid reservoir to be integrated into a miniaturized flow cell, comprising a reservoir space, which is enclosed by two bodies (6,7) that lie against each other in a fluid-tight manner. According to the invention, in addition to a stored liquid (9), a solid filling body (12) that fills the remaining reservoir space is arranged in the reservoir space. A part of the reservoir space filled by the stored liquid is preferably bounded predominately by one of the two bodies (6,7) and the solid filling body (12).
Typical turnaround times for diagnostic prior art assays are 30-120 minutes. Often, the time lost in waiting for laboratory results can lead to a further deterioration in a patient, and sometimes death. In some cases, the physician has to act without having the laboratory results. This can lead to providing the patient with the wrong treatment. There is thus a need to provide rapid assays to save lives and provide fast correct treatments to a patient. Despite the inventions described hereinabove, there still remains an unmet need to provide improved apparatus and methods for detecting and diagnosing biological conditions in a patient.
There are many other diagnostic tests, such as to water samples, to detect toxins and contaminants that currently have a long turnaround. There still is an unmet need to provide systems, kits and methods to provide quantitative and/or qualitative tests for determining a chemical state.